Merck Submits NDA to the Japanese Pharmaceuticals and Medical Devices Agency for Omarigliptin for Type 2 Diabetes
![](/46/pdcnewsitem/03/39/09/Gux1ia9eF1gYMlZ.jpg)
Merck (MSD outside the US and Canada) has submitted a new drug application (NDA) for omarigliptin, its investigational once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes, to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
“Merck is committed to helping patients with type 2 diabetes and we are excited about the submission of the NDA for omarigliptin in Japan,” said Peter Stein, M.D., Vice President, clinical research, diabetes and endocrinology, Merck Research Laboratories.
“More than six million adults in Japan have type 2 diabetes. If approved in Japan, omarigliptin could provide an important new treatment option to help these patients attain their blood sugar goals.”
The NDA for omarigliptin is based on a comprehensive clinical development programme in Japan. The results from the first Phase III study of omarigliptin, conducted in Japan, were presented recently at the 50th European Association for the Study of Diabetes (EASD) Annual Meeting.
Japan is the first country with a regulatory filing for omarigliptin. Worldwide, Merck is supporting omarigliptin with a clinical development programme that includes nine Phase III clinical trials involving approximately 7500 patients with type 2 diabetes in support of planned regulatory filings.
Related News
-
News Global advancements in the diagnosis and treatment of rare diseases: Rare Disease Day 2024
Rare Diseases Day is celebrated on the 29th February 2024 and represents the plight of rare disease patients to gain diagnosis and access to suitable treatment. -
News Pharmaceutical industry supports COP28 health stance in joint statement
As COP28 takes place over this week in Dubai, UAE, several bodies in the pharmaceutical and health industries have come together to announce support of key movements in sustainability in the sector, and to recognise sustainability as a health issue.&nb... -
News Biden backs Cold-War measures to shore-up medical supply chains
In a recent strategy to combat rising inflation and the cost of living crisis, President Joe Biden has invoked a Cold War-era act to increase investment in a selection of medicines and supplies. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Novartis agrees for copies to be made of cancer drug to reach poorer countries
Novartis signs agreement with MPP to have generics of it's leukemia drug made so that it can be more easily distributed to the world's poorer countries. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance